Clinical Trials With a Local Anesthetic Lozenge for the Treatment of Oral Mucosal Pain in Burning Mouth Syndrome, Sjögrens Syndrome and Lichen Planus.
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 31
- 试验地点
- 1
- 主要终点
- Assessment of oral pain on the Visual Analog Scale
研究概览
简要总结
The aim of the project is to do a fase two trial, where the effect of a local anesthetic lozenge will be tested in regard to oral pain, dryness of the mouth, irregularity of taste as well as investigate a potential antiinflammatory effect in patients with burning mouth syndrome, Sjögrens syndrome and lichen planus.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with burning mouth syndrome, Sjögrens syndrome or lichen planus
- •All fertile women need to use save contraception
- •Age between 18 and 75 years
- •Able to speak, read and understand the danish language
- •Must be informed orally and release a written consent and a signed authorization statement
排除标准
- •Pregnant or breastfeeding women
- •Known allergy to bupivacaine or other local anesthetics of the amide type
- •Active infection which requires antibiotic treatment
- •Patients in immune suppressive treatment
研究组 & 干预措施
Placebo lozenge
The patients will be randomized to start two weeks treatment with either a bupivacaine lozenge or a placebo lozenge (taken three times a day). The two weeks treatment is followed by a week without treatment. Afterwards they start another two weeks treatment with the opposite type of lozenge from the first treatment period.
干预措施: Placebo (Drug)
Bupivacaine lozenge
The patient will be randomized to start two weeks treatment with either a bupivacaine lozenge or a placebo lozenge (taken three times a day). The two weeks treatment is followed by a week without treatment. Afterwards the patient starts another two weeks treatment with the opposite type of lozenge from the first treatment period.
干预措施: Bupivacaine (Drug)
结局指标
主要结局
Assessment of oral pain on the Visual Analog Scale
时间窗: The patients assess their oral pain when they attend the four examinations and they fill in a diary for a total of four weeks.
Assessment of oral pain in patients with burning mouth syndrome, Sjögrens syndrome or lichen planus after treatment with a bupivacaine lozenge or a placebo lozenge. The patient assess their oral pain on the visual analog scale when they attend the four examinations. The patients also fill in a diary for a total of four weeks where they are in treatment where they assess VAS for pain, dryness of the mouth and irregularity of taste
次要结局
- Measure the inflammation markers in blood, saliva and tissue(Blood- and saliva samples are taken the four times the patient attend the examinations. They are taken over a periode of five weeks. Tissue samples are taken before the first treatment period starts and when the final treatment period is finished.)
研究者
Anne Marie Lynge Pedersen
Dentist, PhD
University of Copenhagen